New CE mark adds utility for laser platform

Sunnyvale, CA-OptiMedica Corp. has announced that its proprietary platform that combines a femtosecond laser, integrated three-dimensional optical coherence tomography (OCT) imaging, and a proprietary pattern-scanning technology (Catalys Precision Laser System) has been granted CE mark approval for creating single-plane and multi-plane arc cuts/incisions in the cornea during cataract surgery.

The approval adds new utility to the platform, which was previously CE mark approved and FDA market cleared for capsulotomy and lens fragmentation.

According to OptiMedica, the new CE mark indication allows cataract surgeons to perform incisions of precise orientation, length, and depth; multi-plane cataract incisions that are designed to be self-sealing; and single-plane sideport incisions.

“The CE mark approval for corneal incisions is an exciting development that will allow [our proprietary platform] to bring even more value to the laser cataract procedure,” said Mark J. Forchette, OptiMedica president and chief executive officer. “We are thrilled to be able to extend the system’s precision and accuracy benefits to these important surgical steps, as they will further optimize the experience for cataract surgeons and their patients.”

The system’s corneal incisions application is delivered via a software upgrade from OptiMedica and is expected to be available in markets worldwide, pending additional regulatory clearances.

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